PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0


Device Classification Name

tube, tracheal (w/wo connector)

510(k) Number K081086
Device Name PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
Applicant
SMITHS MEDICAL ASD, INC.
military road
hythe, kent, 

GB

ct216jl

Applicant Contact john tullett
Correspondent
SMITHS MEDICAL ASD, INC.
military road
hythe, kent, 

GB

ct216jl

Correspodent Contact john tullett
Regulation Number 868.5730
Classification Product Code
BTR  
Date Received 04/16/2008
Decision Date 08/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No